Closure devices and methods

ABSTRACT

A closure device for closing an opening in tissue is provided. The closure device includes an elongate member through which needles may be deployed. The closure device also includes a closure element having a foot portion and a needle guide portion. The foot portion and the needle guide portion are each movable between a delivery configuration and a deployed configuration. The foot portion includes cuffs removably mounted thereon and having sutures connected therebetween. The needle guide portion includes needle guide apertures that guide the needles to the cuffs. The needles securely engage the cuffs and draw the cuffs and suture through the lumen wall so that the opening in the lumen wall can be closed with the sutures.

CROSS-REFERENCE TO RELATED APPLICATIONS

This is a continuation application of U.S. patent application Ser. No.13/111,576, entitled “Closure Devices and Methods”, filed 19 May 2011,the disclosure of which is incorporated herein by this reference.

BACKGROUND 1. Technical Field

The present disclosure relates generally to techniques and devices forclosing an opening in a body lumen. More particularly, the presentdisclosure relates to systems, devices, and methods for percutaneousclosure of arterial and venous puncture sites, which are usuallyaccessed through a tissue tract.

2. The Relevant Technology

A number of diagnostic and interventional vascular procedures are nowperformed translumenally. A catheter is introduced to the vascularsystem at a convenient access location and guided through the vascularsystem to a target location using established techniques. Suchprocedures require vascular access, which is usually established usingthe well-known Seldinger technique. Vascular access is generallyprovided through an introducer sheath, which is positioned to extendfrom outside the patient's body into the vascular lumen. When vascularaccess is no longer required, the introducer sheath is removed andbleeding at the puncture site stopped.

One common approach for providing hemostasis (the cessation of bleeding)is to apply external force near and upstream from the puncture site,typically by manual compression. This approach suffers from a number ofdisadvantages. For example, the manual compression procedure is timeconsuming, frequently requiring one-half hour or more of compressionbefore hemostasis is achieved. Additionally, such compression techniquesrely on clot formation, which can be delayed until anticoagulants usedin vascular therapy procedures (such as for heart attacks, stentdeployment, non-optical PTCA results, and the like) wear off. Theanticoagulants may take two to four hours to wear off, therebyincreasing the time required before completion of the manual compressionprocedure.

Further, the manual compression procedure is uncomfortable for thepatient and frequently requires analgesics to be tolerable. Moreover,the application of excessive pressure can at times totally occlude theunderlying blood vessel, resulting in ischemia and/or thrombosis.Following manual compression, the patient typically remains recumbentfrom four to as much as twelve hours or more under close observation toassure continued hemostasis. During this time, renewed bleeding mayoccur, resulting in blood loss through the tract, hematoma and/orpseudo-aneurysm formation, as well as arteriovenous fistula formation.These complications may require blood transfusions and/or surgicalintervention.

The incidence of complications from the manual compression procedureincreases when the size of the introducer sheath grows larger, and/orwhen the patient is anticoagulated. The compression technique forarterial closure can be risky, and is expensive and onerous to thepatient. Although using highly trained individuals can reduce the riskof complications, dedicating such personnel to this task is bothexpensive and inefficient. Nonetheless, as the number and efficacy oftranslumenally performed diagnostic and interventional vascularprocedures increases, the number of patients requiring effectivehemostasis for a vascular puncture continues to increase.

To overcome the problems associated with manual compression, the use ofbioabsorbable sealing bodies is one example approach that has beenproposed. Generally, this example approach relies on the placement of athrombogenic and bioabsorbable material, such as collagen, at thesuperficial arterial wall over the puncture site. While potentiallyeffective, this approach suffers from a number of drawbacks. Forexample, bioabsorbable sealing bodies may lack a solid mechanicalattachment of the sealing body to the tissue. Due to the lack of a solidmechanical attachment, the sealing body can wander within the tissuetract or move out of the puncture site, thus causing late bleeds.Conversely, if the sealing body wanders and intrudes too far into thearterial lumen, due to the lack of a solid mechanical attachment,intravascular clots and/or collagen pieces with thrombus attached canform and embolize downstream, causing vascular occlusion.

In addition to not having a solid mechanical attachment to the tissue,the sealing bodies may rely upon expandable materials to achievehemostasis. Again, the expandable materials lack the security of a hardmechanical closure, thus potentially causing late bleeds and prolonginghemostasis.

For these reasons, it would be desirable to provide improved devices andmethods to seal body lumen puncture sites. It would be particularlydesirable to provide percutaneous devices and methods for suturing thepuncture sites required for percutaneous vascular procedures.

BRIEF SUMMARY

This Summary is provided to introduce a selection of concepts in asimplified form that are further described below in the DetailedDescription. This Summary is not intended to identify key features oressential features of the claimed subject matter, nor is it intended tobe used as an aid in determining the scope of the claimed subjectmatter. Embodiments of the present invention provide systems, methods,and devices for closing an opening in tissue. Embodiments of theinvention can be configured to close an opening within a body lumen.

For instance, in one exemplary embodiment, a device for closing anopening in tissue includes a body member that has a proximal portion anda distal portion. The proximal portion includes a plurality of proximalslits disposed therein and the distal portion includes a plurality ofdistal slits disposed therein. The proximal and distal slits cooperatewith the body member to facilitate the proximal portion and distalportion changing from delivery configurations to deployedconfigurations. The proximal portion and the distal portion each changefrom the delivery configuration to the deployed configuration by axiallycompressing and radially expanding. The device can also include one ormore actuators for moving the proximal and distal portions between thedelivery and deployed configurations. The device also includes aplurality of needle guide apertures formed in the proximal portion thatare adapted to have at least one needle pass therethrough. At least onecuff is also removably mounted in the distal portion.

According to another implementation of the present invention, a devicefor closing an opening in a body lumen includes an elongate member, atleast one needle, and a closure element. The elongate member has aproximal end, a distal end, a central passage, and at least one needlelumen extending from the proximal end toward the distal end. The atleast one needle is disposed within and advancable from the at least oneneedle lumen. The closure element extends from the distal end of theelongate member and has a proximal portion, a distal portion, and awaist portion. The proximal portion and the distal portion are eachconfigured to move between a delivery configuration and a deployedconfiguration. The proximal portion includes a plurality of needle guideapertures and the distal portion has at least one cuff removably mountedtherein. The plurality of needle guide apertures guide the at least oneneedle to the at least one cuff when the proximal and distal portionsare in the deployed configurations and as the at least one needle isadvanced from the at least one needle lumen.

In still another exemplary embodiment, a closure device that is used inclosing an opening in a wall of a body lumen includes an elongate memberthat has at least one pair of needle lumens extending therethrough. Atleast one pair of needles are disposed in the at least one pair ofneedle lumens. The at least one pair of needles are selectivelyadvancable from the at least one pair of needle lumens. A closureelement extends from the elongate member and has a longitudinal axis.The closure element includes a foot portion that has a deliveryconfiguration and a deployed configuration. The foot portion is designedto pass through the opening in the wall of the body lumen when the footportion is in the delivery configuration. The foot portion also resistspassage through the opening in the wall of the body lumen when the footportion is in the deployed configuration. The foot portion has at leastone pair of cuffs removably mounted thereon with a length of suturebeing connected between the at least one pair of cuffs. The closureelement also includes a needle guide portion that has a deliveryconfiguration and a deployed configuration. The needle guide portion hasat least one pair of proximal needle guide apertures and at least onepair of distal needle guide apertures. The proximal and distal needleguide apertures guide the at least one pair of needles toward the atleast one pair of cuffs when the needle guide portion is in the deployedconfiguration and as the at least one pair of needles are advanced fromthe at least one pair of needle lumens.

These and other advantages and features of the present invention willbecome more fully apparent from the following description and appendedclaims, or may be learned by the practice of the invention as set forthhereinafter.

BRIEF DESCRIPTION OF THE DRAWINGS

To further clarify the above and other advantages and features of thepresent invention, a more particular description of the invention willbe rendered by reference to specific embodiments thereof which areillustrated in the appended drawings. It is appreciated that thesedrawings depict only typical embodiments of the invention and aretherefore not to be considered limiting of its scope. The invention willbe described and explained with additional specificity and detailthrough the use of the accompanying drawings in which:

FIG. 1 is an elevation view of a closure device in accordance with oneembodiment of the present invention;

FIG. 2 is a close-up view of the distal end of the closure device ofFIG. 1 in a deployed configuration;

FIG. 2A is a close-up view of the distal end of an alternativeembodiment of a closure device, the closure device having suture reliefslots formed therein;

FIG. 3 is a cross-sectional view of the distal end of the closure deviceof FIG. 1 in a delivery configuration;

FIG. 4 is a view similar to FIG. 3, except that a foot portion of thedistal end has been expanded;

FIG. 5 is a view similar to FIG. 4, except that a needle guide portionof the distal end has been expanded;

FIG. 6 is a close-up view of the distal end of the closure device ofFIG. 1 inserted partially into a vessel through a puncture site;

FIG. 7 is a view similar to FIG. 6, except that the foot portion of thedistal end has been expanded within the vessel;

FIG. 8 is a view similar to FIG. 7, except that the needle guide portionof the distal end has been expanded outside the vessel so that thevessel wall is held between the foot portion and the needle guideportion;

FIG. 9 is a view similar to FIG. 8, except that needles have beendeployed through the needle guides, through the vessel wall, and towardscuffs mounted on the foot portion;

FIG. 9A is a detail view taken from FIG. 9, showing a needle passingthrough the needle guides, the vessel wall, and toward a cuff in thefoot portion;

FIG. 10 is a view similar to FIG. 9, except that the needles have beendrawn proximally after engaging the cuffs, thereby drawing the cuffs andattached sutures through the vessel wall;

FIG. 11 illustrates the needles completely withdrawn into the elongatemember and the foot and needle guide portions collapsed prior to removalof the distal end from the vessel; and

FIG. 12 illustrates the sutures tied to close the opening in the vesselwall.

DETAILED DESCRIPTION

As used herein, the term “distal” is generally defined as in thedirection of the patient or away from a user of a device. In the contextof a medical device intervention with or through a vessel wall, “distal”herein refers to the interior or the lumen side of the vessel wall.Conversely, “proximal” generally means away from the patient or towardthe user. In the context of a medical device intervention with orthrough a vessel wall, “proximal” herein refers to the exterior or outerside of the vessel wall.

The term “suturing” is herein intended to include the process of joiningtwo surfaces or edges together with a fastener or so as to close anaperture, opening, or wound, or join tissues. The fastener is usually asuture such as a thread of material (either polymeric or natural), gut,wire, or the like. The term fastener as used herein also includesclamps, studs, hasps, catches, hooks, rivets, staples, snaps, stitches,VELCROC, buttons, and other coupling members.

Referring to FIGS. 1-5, a suture applying device which is suitable forsuturing and sealing of percutaneous vascular puncture sites, such asthose made to the femoral artery in a patient's groin, will bedescribed. It will be appreciated, however, that the device of thepresent invention can be readily adapted for use with punctures made toother hollow body organs and lumens, although it may be necessary tomodify the dimensions and other particular aspects of the device toaccommodate the different usage environments.

FIG. 1 illustrates one example embodiment of a closure device 100.Closure device 100 includes a proximal end 102 and a distal end 104. Asshown in FIG. 1, closure device 100 includes an elongate member 106 thathas a proximal end 108 and a distal end 110. As discussed in greaterdetail below, elongate member 106 also includes one or more lumens thatextend generally from proximal end 108 to distal end 110. The one ormore lumens may be used to facilitate the delivery of device 100 over aguidewire or to delivery one or more needles into a patient. Elongatemember 106 is generally tubular and includes a handle 112 at proximalend 108 to facilitate manipulation of device 100 or elongate member 106.In one embodiment elongate member 106 is formed of a rigid material suchas a stainless steel or other biocompatible material that is rigid.Alternatively, elongate member 106 may be formed of a flexible materialsuch as those materials utilized to form catheter shafts, introducersheaths, or other medical devices. Suitable materials include polyvinylchloride (PVC), peak, PTFE, nylon, or any other similar materials.

Extending beyond distal end 110 of elongate member 106 is a closureelement 114. Closure element 114 is also a hollow, generally tubularshaped member and includes a foot portion 116, a needle guide portion118, and a tip 142. As shown in FIG. 1, foot portion 116 and needleguide portion 118 are each in a delivery configuration that allowsclosure element 114 to be inserted into a patient. Once inserted, footportion 116 and needle guide portion 118 can be selectively expanded andsubsequently collapsed as discussed below. Handles 120, 122 at proximalend 102 of closure device 100 are operably connected to foot portion 116and needle guide portion 118, respectively, such that handles 120, 122can be used to selectively expand and collapse foot portion 116 andneedle guide portion 118.

As alluded to above, closure device 100 also includes one or moreneedles that can be deployed from one or more lumens (such as needlelumen 124) in elongate body 106 into a patient. The one or more needlescan be advanced through the needle lumens and into the patient usinghandle 126. More specifically, handle 126 may be linked to or operablyassociated with the one or more needles such that the one or moreneedles advance out of the needle lumens and into the patient as handle126 is moved distally (i.e., towards distal end 104). Likewise, handle126 may be adapted to withdraw the one or more needles out of thepatient and back into the needle lumens when handle 126 is movedproximally (i.e., away from distal end 104).

Foot portion 116 includes one or more cuffs 128 removably mountedtherein. A length of suture 130 is connected to each cuff 128. In theillustrated embodiment, a length of suture is connected between eachpair of cuffs 128. When foot portion 116 is deployed in a vessel and theneedles are deployed from elongate member 106 into the patient, eachneedle engages and connects to a cuff 128. Needle guide portion 118includes proximal and distal needle guide apertures 132, 134 that arearranged on needle guide portion 118 so as to receive the needlestherethrough when the needles are deployed from elongate member 106.Needle guide apertures 132, 134 are adapted to guide the needles towardcuffs 128. When the needles are subsequently withdrawn out of thepatient, the needles withdraw cuffs 128 out of the patient as well.Drawing cuffs 128 out of the patient pulls sutures 130 through thevessel wall so that sutures 130 may be tied to close a puncture in thevessel wall.

Foot portion 116 and needle guide portions 118 include slits 136, 138,respectively, that enable or facilitate the expansion and contraction offoot portion 116 and needle guide portion 118. The geometricconfiguration of slits 136, 138, as shown in FIG. 1, may be a generallyrectangular configuration. However, in other example embodiments thegeometric configuration of slits 136 and/or slits 138 may take variousother geometric configurations such as more square, triangular, oval orany other configuration or combination of configurations. Slits 136, 138may be formed within the wall of closure element 114 using knownmanufacturing techniques such as cutting, laser cutting, water jetcutting. Alternatively, slits 136, 138 may be integrally formed withinclosure element 114 during manufacturing such as through the use ofinjection molding.

Furthermore, and as illustrated in the example embodiment of FIG. 1,slits 136 may have substantially the same configuration and dimensionsas slits 138. In other example embodiments, however, slits 136 and slits138 may have different geometric configuration and/or dimension comparedto one another. For example, in one embodiment, slits 136 may have adifferent length and width as slits 138, or slits 136 may have adifferent geometric configuration relative to slits 138.

In addition to variations between slits 136 and slits 138, the geometricconfiguration and the dimensions of slits 136 and/or slits 138 may varyfrom one slit to the next. For instance, slits 136 may have a variety ofdifferent sized and configured slits that make up the plurality of slits136. Similarly, slits 138 may be made up of a variety of different sizedand configured individual slits.

The distance between slits 136 and slits 138 is another aspect ofclosure element 114 that may vary from one embodiment to the next. Inone example embodiment, the distance between slits 136 and slits 138 isa distance that would be approximately equal to the width of a bodylumen wall. For example, the distance between slits 136, 138 may beequal to the width of the proximal lumen wall 156, illustrated in FIGS.6-11. The area of closure element 114 between slits 136, 138 may bereferred to as a waist 140. Thus, waist 140 may have a length that isabout equal to the width of a lumen wall.

Attention is now directed to FIG. 2, which illustrates a perspectiveview of distal end 104 of closure device 100 with foot portion 116 andneedle guide portion 118 deployed to their expanded configurations. Inthe illustrated embodiment, foot portion 116 and needle guide portion118 expand generally radially out in four directions to form generallycross shapes. More specifically, foot portion 116 includes four segmentsor legs 116A, 116B, 116C, 116D that extend away from longitudinal axis Aof device 100 in four different directions. Likewise, needle guideportion 118 includes four segments or legs 118A, 118B, 118C, 118D thatextend away from axis A in four different directions. Slits 136, 138 inrespective foot portion 116 and needle guide portion 118 at leastpartially define legs 116A, 116B, 116C, 116D, 118A, 118B, 118C, 118D.More specifically, the area between two radially adjacent slits 136defines a leg or segment of foot portion 116, and the area between tworadially adjacent slits 138 defines a leg or segment of needle guideportion 118. Slits 136, 138 allow legs 116A, 116B, 116C, 116D, 118A,118B, 118C, 118D to radially expand as discussed herein.

In the illustrated embodiment, corresponding legs from foot portion 116and needle guide portion 118 are aligned with one another. For instance,legs 116A and 118A are radially aligned with one another, legs 116B and118B are radially aligned with one another, and so on. As a result, thedistal opening of each needle lumen 124 is generally aligned with a legor segment from needle guide portion 118 and foot portion 116. Thealignment between the distal opening of each needle lumen 124 and thelegs or segments of needle guide portion 118 and foot portion 116 alsoprovides for alignment between the distal opening of each needle lumen124 and a proximal needle guide aperture 132 and a distal needle guideaperture 134 in needle guide portion 118, as well as with a cuff 128removably mounted in foot portion 116, when foot portion 116 and needleguide portion 118 are in the deployed configuration.

Although the distal opening of each needle lumen 124 is generallyaligned with a proximal needle guide aperture 132, a distal needle guideaperture 134, and a cuff 128, this alignment is not necessarily parallelto longitudinal axis A of device 100. Rather, when closure element 114is expanded as shown in FIG. 2, proximal needle guide apertures 132 arespaced radially further away from axis A than the distal openings ofneedle lumens 124. Similarly, distal needle guide apertures 134 arespaced radially further away from axis A than proximal needle guideapertures 132. Likewise, cuffs 128 are spaced radially further away fromaxis A than distal needle guide apertures 134. It will be understoodthat needle lumens 124, proximal needle guide apertures 132, distalneedle guide apertures 134, and cuffs 128 may also be radially displacedor offset from one another about axis A. Accordingly, the needles mayextend radially about axis A as the needles are deployed through needlelumens 124, proximal needle guide apertures 132, and distal needle guideapertures 134, and into cuffs 128.

As shown in FIGS. 1 and 2, cuffs 128 are supported by foot portion 116and sutures 130 extend from cuffs 128 so that cuffs 128 and sutures 130are readily releasable from closure element 114. As shown in FIG. 1, forinstance, sutures 130 extend from cuffs 128 toward the outside ofclosure element 114 (when foot portion 116 is in the deliveryconfiguration; or toward the top of foot portion 116 when foot portionis in the expanded configuration as shown in FIG. 2) so that sutures 130are disposed substantially outside closure element 114. As a result,when foot portion 116 is moved to the expanded position shown in FIG. 2,sutures 130 extend out over the top of foot portion 116. As will beappreciated, positioning cuffs 128 and sutures 130 in this manner allowscuffs 128 and sutures 130 to be readily removed from foot portion 116 sothat closure element 114 may be removed from a vessel and sutures 130may be used to close a puncture site in the vessel.

Although FIGS. 1 and 2 illustrate sutures 130 extending out of closureelement 114, sutures 130 may also extends toward the inside of closureelement 114. For instance, FIG. 2A illustrates an alternative embodimentof a closure element 114′. Closure element 114′ is similar to identicalto closure element 114 in many respects. However, sutures 130′ extendfrom cuffs 128′ toward the inside of closure element 114′ (when footportion 116′ is in the delivery configuration; or toward the bottom offoot portion 116′ when foot portion is in the expanded configuration asshown in FIG. 2A). To allow sutures 130′ to be released from or preventsutures 130′ from being caught in foot portion 116′ when sutures 130′are passed through a vessel wall or when closure element 114′ is removedfrom a vessel, foot portion 116′ may include one or more suture reliefslits on each of foot portion leg 116A, 116B, 116C, 116D.

For instance, as shown in FIG. 2A, legs 116A, 116B, 116C, 116D includesuture relief slits 117A, 117B, 117C, 117D, respectively. In theillustrated embodiment, suture relief slits 117A, 117B, 117C, 117Dextend along a length of legs 116A, 116B, 116C, 116D and are sized toallow sutures 130′ to pass therethrough as shown. When cuffs 128′ areremoved from foot portion 116′, sutures 130′ are able to slide out ofsuture relief slits 117A, 117B, 117C, 117D, thereby separating orreleasing sutures 130′ from foot portion 116′. Sutures 130′ may also beseparated or released from foot portion 116′ when foot portion 116′ ismoved from the illustrated expanded configuration to a deliveryconfiguration similar to that shown in FIG. 1. As foot portion 116′ ismoved from the expanded configuration to the delivery configuration,sutures 130′ may slide out of suture relief slits 117A, 117B, 117C,117D, thereby separating or releasing sutures 130′ from foot portion116′.

While suture relief slits 117A, 117B, 117C, 117D have been shown anddescribed as being generally linear slits extending along the length oflegs 116A, 116B, 116C, 116D, suture relief slits may be formed in otherways. For instance, FIG. 2A also illustrates in phantom lines suturerelief slits 119A, 119B, 119C, 119D that extend from cuffs 128′ towardthe sides of legs 116A, 116B, 116C, 116D. Like slits 117A, 117B, 117C,117D, slits 119A, 119B, 119C, 119D may be sized to allow sutures 130′ topass therethrough to separate or release sutures 130′ from foot portion116′. Slits 119A, 119B, 119C, 119D may be oriented perpendicularly toslots 136. Alternatively, slits 119A, 119B, 119C, 119D may be at someother angle relative to slots 136 to allows sutures 130′ to more easilypass therethrough when cuffs 128′ are removed from foot portion 116′ orwhen foot portion 116′ is moved from an expanded configuration to adelivery configuration.

Attention is now directed to FIGS. 3-5, which illustrate cross-sectionalviews of distal end 104 of the embodiment shown in FIGS. 1 and 2, andhow closure element 114 is deployed from a delivery configuration to anexpanded or a deployed configuration. Although FIGS. 3-5 illustratespecific types of mechanisms for moving closure element 114 between thedelivery and deployed configuration, it will be understood that thesemechanisms are merely exemplary. One of ordinary skill in the art willrecognize other mechanisms that may be employed to move closure element114 between the delivery and deployed configurations.

With specific reference to FIG. 3, a cross-sectional view of distal end104 is illustrated in the delivery configuration. In other words, distalend 104 may be inserted at least partially into a patient when distalend 104 is in the configuration shown in FIG. 3. As mentioned above,elongate member 106 includes a plurality of needle lumens 124. Eachneedle lumen 124 is designed to have a needle 144 positioned therein. Asshown in FIG. 3, needles 144 may be positioned within needle lumens 124such that the distal tips 146 thereof are positioned within needlelumens 124. The distal ends of needle lumens 124 open on an outercircumferential surface of elongate member 106. As a result, upon distalmovement of handle 126 (FIG. 1), distal tips 146 of needles 144 aredeployed out of the distal ends of needle lumens 124 in a direction thatis both away from proximal end 102 and radially away from axis A.

According to the presently illustrated embodiment, closure element 114extends both beyond distal end 110 of elongate member 106 as well as atleast partially into elongate member 106. Nevertheless, in otherembodiments closure element 114 does not extend into elongate member106. For instance, closure element 114 may be attached to or integrallyformed on distal end 110 of elongate member 106 without extendingsubstantially into elongate member 106.

In some embodiments it is desirable to link closure element 114 andelongate member 106 together such that a portion of closure element 114and elongate member 106 do not move relative to one another whileanother portion of closure element 114 is able to move relative toelongate member 106. For instance, as discussed in greater detail below,during deployment it may be desirable to prevent the proximal end ofclosure element 114 from moving into or relative to elongate member 106while allowing one or more other portions of closure element 114 to moverelative to elongate member 106. Accordingly, a retaining ring 148 isdisposed between elongate member 106 and closure element 114. Retainingring 148 may be a mechanical fastener or member that is attached to bothelongate member 106 and closure element 114 so as to prevent relativemovement therebetween. Alternatively, retaining ring 148 may create afriction fitting between elongate member 106 and closure element 114.Retaining ring 148 may also be an adhesive that connects elongate member106 and closure element 114. Still further, retaining ring 114 may be afeature formed on one or both of elongate member 106 and closure element114 that prevents relative movement. In other embodiments, retainingring 148 may be omitted when elongate member 106 and closure element 114are integrally formed.

As shown in FIG. 3, device 100 also includes rods 150, 152. Rod 150 isconnected between handle 120 (FIG. 1) and tip 142 (or, alternatively,the distal end of foot portion 116), and rod 152 is connected betweenhandle 122 (FIG. 1) and waist 140 (or, alternatively, the distal end ofneedle guide portion 118). Rods 150, 152 are adapted to move footportion 116 and needle guide portion 118 from the delivery configurationto the deployed configuration when handles 120, 122 are movedproximally.

With reference to FIG. 4, the manner in which foot portion 116 is movedto the deployed configuration will be discussed. In order to move footportion 116 from the delivery configuration shown in FIGS. 1 and 3 tothe deployed configuration shown in FIG. 4, rod 152 is held stationaryvia handle 122 while rod 150 is moved proximally in the direction ofarrow A₁. The proximal movement of handle 120 causes tip 142 to alsomove proximally in the direction of arrow A₁. By holding rod 152stationary, waist 140 is held stationary relative to tip 142. As aresult of waist 140 staying stationary and tip 142 moving proximally,foot portion 116 is axially compressed when rod 150 is moved proximallyand rod 152 is held stationary. Slits 136 and the axial compression offoot portion 116 causes foot portion legs 116A, 116B, 116C, 116D to foldor otherwise radially expand as shown in FIGS. 2 and 4. When footportion 116 is moved to the deployed configuration, cuffs 128 facegenerally proximally toward needle lumens 124. Accordingly, when footportion 124 is in the deployed configuration, cuffs 128 are oriented sothat needles 144 may be deployed and engage cuffs 128, as will bediscussed in detail below.

Once foot portion 116 has been moved to the deployed configuration,needle guide portion 118 can also be moved to the deployedconfiguration. As shown in FIG. 5, moving needle guide portion 118 tothe deployed configuration can be accomplished by moving rod 152, viahandle 122 (FIG. 1), proximally in the direction of arrow A₂. Proximalmovement of rod 152 causes waist 140 to also move proximally in thedirection of arrow A₂. The connection made between closure element 114and elongate member 106 with retaining ring 148 prevents the proximalend of needle guide portion 118 from moving proximally as rod 152 ismoved proximally. As a result of the proximal end of needle guideportion 118 staying stationary and waist 140 moving proximally, needleguide portion 118 is axially compressed when rod 152 is movedproximally. Slits 138 and the axial compression of needle guide portion118 causes needle guide legs 118A, 118B, 118C, 118D to fold or otherwiseradially expand as shown in FIGS. 2 and 5. When needle guide portion 118is moved to the deployed configuration, needle guides apertures 132, 134are aligned between needle lumens 124 and cuffs 128. Accordingly, whenneedle guide portion 118 is in the deployed configuration, needle guideapertures 123, 134 are positioned so that needles 144 may be deployedtherethrough and guided into cuffs 128, as discussed herein.

As will be appreciated, foot and needle guide portions 116, 118 may bemoved back to the delivery configuration shown in FIG. 3 by generallyreversing the previously described steps. For instance, needle guideportion 118 may be moved from the deployed configuration shown in FIG. 5back to the delivery configuration by moving rod 152, via handle 122(FIG. 1), distally in a direction generally opposite to the direction ofarrow A₂ and relative to elongate member 106. By moving rod 152 distallyand relative to elongate member 106, needle guide portion 118 is axiallyexpanded, thereby causing needle guide legs 118A, 118B, 118C, 118D tounfold or be drawn radially inward toward axis A and back to thedelivery configuration shown in FIG. 3.

Likewise, foot portion 116 may be moved from the deployed configurationshown in FIGS. 4 and 5 back to the delivery configuration shown in FIG.3 by moving rod 150, via handle 120 (FIG. 1), distally in a directiongenerally opposite to the direction of arrow A₁ and relative to rod 152(and thus waist 140). By moving rod 150 distally and relative to rod152, foot portion 116 is axially expanded, thereby causing foot legs116A, 116B, 116C, 116D to unfold or be drawn radially inward toward axisA and back to the delivery configuration shown in FIG. 3.

With reference to FIGS. 6-12, one exemplary method of using device 100will be discussed. As shown in FIG. 6, distal end 104 of device 100 isinserted into a patient such that foot portion 116 passes through apuncture 154 in a lumen wall 156. As with many transluminal procedures,device 100 may be introduced into the body lumen using a guidewire GW.Once foot portion 116 is positioned within the body lumen, foot portion116 is moved to the delivery configuration as shown in FIG. 7. Asdiscussed above, foot portion may be moved to the deployed configurationby holding rod 152 (via handle 122) stationary while moving rod 150 (viahandle 120) proximally, thereby axially compressing and radiallyexpanding foot portion 116. Once foot portion 116 is in the deployedconfiguration, device 100 may be moved proximally so that foot portionlegs 116A, 116B, 116C, 116D engage the interior surface of lumen wall156. In this manner foot legs 116A, 116B, 116C, 116D may be used aslocators to ensure proper placement of closure element 114 within thebody lumen.

Once foot portion 116 has been deployed and positioned within the bodylumen as desired, needle guide portion 118 is deployed as shown in FIG.8. As noted above, needle guide portion 118 is moved to the deployedposition by drawing rod 152 (via handle 122) proximally, thereby axiallycompressing and radially expanding needle guide portion 118. As can beseen in FIG. 8, when foot and needle guide portions 116, 118 aredeployed, lumen wall 156 is held therebetween and closure element 114substantially closes off puncture 154.

Once closure element 114 is deployed as shown in FIG. 8, needles 144 areadvanced from needle lumens 124 as shown in FIG. 9. As discussed above,needles 144 may be advanced out of needle lumens by moving handle 126(FIG. 1) distally. The advancement of needles 144 out of needle lumens124 causes needles 144 to extend distally and at least partiallyradially away from axis A. More specifically, as shown in FIG. 9A,needles 144 extend out of needle lumens 124 at an angle relative to axisA so that needles 144 will pass through lumen wall 156. Needle guideapertures 132, 134 are aligned with needle lumens 124 and cuffs 128 sothat needles 144 will pass through needle guide apertures 132, 134 andto cuffs 128 upon advancement of needles 144 out of needle lumens 124.

As discussed above, proximal needle guide apertures 132, distal needleguide apertures 134, and cuffs 128 are progressively spaced radiallyfurther away from axis A and are aligned with needle lumens 124. Thearrangement of proximal needle guide apertures 132 and distal needleguide apertures 134 is designed to guide needles 144 to cuffs 128 asshown in FIG. 9A. Thus, as needles 144 extend distally and radiallyfurther away from axis A, needles 144 will pass through proximal needleguide aperture 132, then through distal needle guide aperture 134, andthen into cuff 128.

Once needle 144 is inserted into cuff 128, needle tip 146 securelyengages cuff 128 to connect cuff 128 to needle 144. Needle tip 146 maysecurely engage cuff 128 in any suitable manner. For instance, as shownin FIG. 9A, needle tip 146 may be generally conical in shape with aproximal surface, and cuff 128 may have a receptacle with one or morefeatures, such as tabs, protrusions, or the like, that engage theproximal surface of needle tip 146. When needle tip 146 is receivedwithin cuff 128, the one or more features engage the proximal surface ofneedle tip 146 and prevent needle tip 146 from being removed from cuff128.

With needle tips 146 securely connected to cuffs 128, needles 144 may bewithdrawn out of the patient by moving handle 126 proximally. As needles144 are withdrawn, cuffs 128 are also withdrawn out of the patient. Morespecifically, since cuffs 128 are securely connected to needles 144,withdrawal of needles 144 also causes cuffs 128 to be withdrawn. Evenmore specifically, as shown in FIG. 10, as needles 144 are drawn backthrough lumen wall 156, through distal needle guide aperture 134, andthrough proximal needle guide aperture 132, cuffs 128 are likewise drawntherethrough. As can also be seen in FIG. 10, since suture 130 isconnected between cuffs 128, the ends of suture 130 are also drawnthrough lumen wall 156. As a result, the opposing ends of each suture130 extend through opposing sides of lumen wall 156 so that each suture130 spans puncture 154.

Needles 144 may be withdrawn completely back into needle lumens 124along with cuffs 128 as shown in FIG. 11. Needle guide portion 118 andfoot portion 116 are then moved back to the delivery configuration asalso shown in FIG. 11. As discussed above, needle guide portion 118 ismoved from the deployed configuration to the delivery configuration bymoving rod 152, via handle 122, distally to axially expand and radiallycontract needle guide portion 118. Similarly, foot portion 116 is movedfrom the deployed configuration to the delivery configuration by movingrod 150, via handle 120, distally to axially expand and radiallycontract foot portion 116.

Once needle guide portion 118 and foot portion 116 are in the deliveryconfiguration, closure element 114 can be removed from the patient,leaving sutures 130 spanning puncture 154 and extending out of lumenwall 156. Sutures 130 can be secured to close puncture 154 as shown inFIG. 12. Sutures 130 can be secured in any suitable manner, including bytying or with clamps, clips, or other closure devices.

Although closure device 100 has been described herein in particulardetail, it will be appreciated that a closure device according to thepresent invention may take other forms or include various modificationsto the devices described herein. By way of non-limiting example, closureelement 114 may be formed of a resilient or superelastic material thatmay be selectively deformed through the application of force and thenreturn to a natural or predefined shape when the force is removed.

Forming closure element 114 of a resilient or superelastic material cansimplify the procedure for moving foot and needle guide portions 116,118 from the deployed configuration to the delivery configuration. Forinstance, closure element 114 may have a natural or predefined shapesimilar to that shown in FIG. 1. Closure element 114 may be deployed ina manner similar to that described herein (i.e., moving handles 120, 122proximally). That is, a force or forces may be applied to foot portion116 and needle guide portion 118 to cause axially compression andradially expansion as described herein. However, rather than having toapply a force or forces (i.e., moving handles 120, 122 distally) to movefoot and needle guide portions 116, 118 back to the deliveryconfiguration, the resilient or superelastic nature of closure element114 can automatically return foot and needle guide portions 116, 118back to the delivery configuration when the original force(s) areremoved. That is, after handles 120, 122 have been drawn proximally todeploy closure element 114, handles 120, 122 can simply be let go andthe resilient or superelastic nature of closure element will cause footand needle guide portions 116, 118 to return to the deliveryconfiguration without requiring the user to affirmatively move handles120, 122 distally.

In connection with forming closure element 114 of a resilient orsuperelastic material, rod 150 may be formed a non-rigid material, suchas a thread, cable, rope, or the like. The non-rigid rod 150 would stillbe able to be pulled proximally to move foot portion 116 to the deployedconfiguration as discussed herein. However, there would no longer be aneed to push on rod 150 to move foot portion 116 back to the deliveryconfiguration since the resilient nature of foot portion 116 wouldautomatically move foot portion 116 back to the delivery configurationonce handle 120 is let go. As a result, rod 150 would not need to berigid to push foot portion 116 back to the delivery configuration.

In still another exemplary embodiment, closure element 114 may be formedof a shape memory material and designed to be positioned within elongatemember 106 and selectively extended out of distal end 110 of elongatemember 106. As is understood by one of ordinary skill in the art, shapememory materials may be formed into a desired shape and heat-set so thatthe material “remembers” the desired shape. The material can then bebent, straightened, compacted, and placed into various contortions bythe application of requisite forces; however, after the forces arereleased the shape memory material can be capable of returning to thememory shape.

With regard to closure element 114 being formed of a shape memorymaterial, closure element 114 may be configured in the deployedconfiguration shown in FIGS. 2, 5, and 8-10 and then heat-set so thatthe material retains the deployed shape. Once closure element 114 hasbeen heat-set in the deployed configuration shape, closure element 114can be straightened into the delivery configuration shown in FIGS. 1 and3 and inserted into elongate member 106. Elongate member 106 can bedesigned to maintain closure element 114 in the delivery configurationwhile closure element 114 is positioned therein.

In use, elongate member 106 (with closure element 114 disposed therein)is inserted into the patient until distal end 110 of elongate member 106is positioned adjacent the exterior surface of lumen wall 156 and acrosspuncture 154. Once so positioned, closure element 114 can be extendedout of elongate member 106, through puncture 154, and into the bodylumen. As closure element 114 extends out of elongate member 106,closure element 114 will return to the memory shape (i.e., the deployedconfiguration shape). Thus, as foot portion 116 is extended out ofelongate member 106 and into the body lumen, foot portion 116 willautomatically move to the deployed configuration. Once foot portion 116is positioned within the body lumen as desired, elongate member 106 maybe withdrawn proximally to uncover needle guide portion 118. As needleguide portion 118 is uncovered, needle guide portion 118 willautomatically move to the memory shape (i.e., the deployed configurationshape). Needles 144 can then be deployed and withdrawn as describedabove. After needles 144 have been withdrawn, closure element 114 can beretracted back into elongate member 106 and removed from the patient.More specifically, closure element 114 may be designed so that needleguide portion 118 and foot portion 116 collapse back to the deliveryconfiguration as closure element 114 is pulled proximally against distalend 110 of elongate member.

While exemplary embodiments have been described herein with particulardetail, including various combinations of particular aspects, features,structure, and functions, it will be appreciated that the presentinvention may include combinations other than those described inparticular detail above. For instance, in one aspect of the disclosure,a device for closing an opening in tissue includes a body member havinga proximal portion, a distal portion, and a waist portion locatedbetween the proximal portion and the distal portion.

In another aspect that may be combined with any of the aspects herein,the proximal portion and the distal portion each have a deliveryconfiguration and a deployed configuration.

In another aspect that may be combined with any of the aspects herein, aplurality of proximal slits are disposed in the proximal portion of thebody member.

In another aspect that may be combined with any of the aspects herein,the proximal slits cooperate with the body member to facilitate theproximal portion changing from the delivery configuration to thedeployed configuration.

In another aspect that may be combined with any of the aspects herein, aplurality of distal slits are disposed in the distal portion of the bodymember.

In another aspect that may be combined with any of the aspects herein,the distal slits cooperate with the body member to facilitate the distalportion changing from the delivery configuration to the deployedconfiguration.

In another aspect that may be combined with any of the aspects herein, aplurality of needle guide apertures are formed in the proximal portionand are adapted to have at least one needle pass therethrough.

In another aspect that may be combined with any of the aspects herein,at least one cuff is removably mounted in the distal portion.

In another aspect that may be combined with any of the aspects herein,the delivery configurations have smaller cross-sectional sizes than thedeployed configurations.

In another aspect that may be combined with any of the aspects herein,the device also includes a first actuator operatively associated withthe body member to cause the distal portion to change between thedelivery configuration and the deployed configuration.

In another aspect that may be combined with any of the aspects herein,the first actuator comprises a rod connected to the distal end of thebody member.

In another aspect that may be combined with any of the aspects herein,the rod has a handle disposed at a proximal end of the device.

In another aspect that may be combined with any of the aspects herein,the device also includes a second actuator operatively associated withthe body member to cause the proximal portion to change between thedelivery configuration and the deployed configuration.

In another aspect that may be combined with any of the aspects herein,the second actuator comprises a rod connected to the waist portion ofthe body member.

In another aspect that may be combined with any of the aspects herein,the rod has a handle disposed at a proximal end of the device.

In another aspect that may be combined with any of the aspects herein,the proximal and distal portions each change from the deliveryconfiguration to the deployed configuration by axially compressing andradially expanding.

In another aspect that may be combined with any of the aspects herein,the plurality of needle guide apertures and the at least one cuff arealigned with one another.

In another aspect that may be combined with any of the aspects herein,the at least one cuff comprises two cuffs.

In another aspect that may be combined with any of the aspects herein, alength of suture is connected between the two cuffs.

In another aspect that may be combined with any of the aspects herein, adevice for closing an opening in a body lumen includes an elongatemember having a proximal end, a distal end, a central passage and atleast one needle lumen extending from the proximal end toward the distalend.

In another aspect that may be combined with any of the aspects herein,at least one needle is disposed within and advancable from the at leastone needle lumen.

In another aspect that may be combined with any of the aspects herein, aclosure element extends from the distal end of the elongate member.

In another aspect that may be combined with any of the aspects herein,the closure element has a proximal portion, a distal portion, and awaist portion.

In another aspect that may be combined with any of the aspects herein,the proximal portion and the distal portion are each configured to movebetween a delivery configuration and a deployed configuration.

In another aspect that may be combined with any of the aspects herein,the proximal portion comprises a plurality of needle guide apertures andthe distal portion has at least one cuff removably mounted therein.

In another aspect that may be combined with any of the aspects herein,the plurality of needle guide apertures guide the at least one needle tothe at least one cuff when the proximal and distal portions are in thedeployed configurations and as the at least one needle is advanced fromthe at least one needle lumen.

In another aspect that may be combined with any of the aspects herein,the closure element further comprises a plurality of proximal slits anda plurality of distal slits that facilitate the movement of the proximalportion and the distal portion between the delivery configuration andthe deployed configuration.

In another aspect that may be combined with any of the aspects herein,the distal portion and the proximal portion are independently movablebetween the delivery configurations and the deployed configurations.

In another aspect that may be combined with any of the aspects herein,the at least one cuff is disposed radially further away from alongitudinal axis of the device than the plurality of needle guideapertures when the proximal and distal portions are in the deployedconfigurations.

In another aspect that may be combined with any of the aspects herein,the plurality of needle guide apertures comprises at least one proximalneedle guide aperture and at least one distal needle guide aperture.

In another aspect that may be combined with any of the aspects herein,the at least one distal needle guide aperture is disposed radiallyfurther away from a longitudinal axis of the device than the at leastone proximal needle guide aperture when the proximal and distal portionsare in the deployed configurations.

In another aspect that may be combined with any of the aspects herein, aclosure device for use in closing an opening in a wall of a body lumenincludes an elongate member having at least one pair of needle lumensextending therethrough.

In another aspect that may be combined with any of the aspects herein,at least one pair of needles are disposed in the at least one pair ofneedle lumens.

In another aspect that may be combined with any of the aspects herein,the at least one pair of needles are selectively advancable from the atleast one pair of needle lumens.

In another aspect that may be combined with any of the aspects herein, aclosure element has a longitudinal axis and includes a foot portion anda needle guide portion.

In another aspect that may be combined with any of the aspects herein,the foot portion has a delivery configuration and a deployedconfiguration.

In another aspect that may be combined with any of the aspects herein,the foot portion is configured to pass through the opening in the wallof the body lumen when in the delivery configuration and resist passagethrough the opening in the wall of the body lumen when in the deployedconfiguration.

In another aspect that may be combined with any of the aspects herein,the foot portion has at least one pair of cuffs removably mountedthereon.

In another aspect that may be combined with any of the aspects herein, alength of suture is connected between the at least one pair of cuffs.

In another aspect that may be combined with any of the aspects herein,the needle guide portion has a delivery configuration and a deployedconfiguration.

In another aspect that may be combined with any of the aspects herein,the needle guide portion has at least one pair of proximal needle guideapertures and at least one pair of distal needle guide apertures.

In another aspect that may be combined with any of the aspects herein,the proximal and distal needle guide apertures guide the at least onepair of needles toward the at least one pair of cuffs when the needleguide portion is in the deployed configuration and as the at least onepair of needles are advanced from the at least one pair of needlelumens.

In another aspect that may be combined with any of the aspects herein,the at least one pair of needles is adapted to securely engage the atleast one pair of cuffs.

In another aspect that may be combined with any of the aspects herein,the at least one pair of needles and the least at least one pair ofcuffs are adapted to be withdrawn together to pull the length of suturethrough the wall of the body lumen.

In another aspect that may be combined with any of the aspects herein,the foot portion is adapted to be used as a locator when positionedwithin the body lumen and moved to the deployed configuration.

In another aspect that may be combined with any of the aspects herein,the device also includes a first actuator and a second actuator.

In another aspect that may be combined with any of the aspects herein,the first actuator is adapted to move the needle guide portion betweenthe delivery and deployed configurations.

In another aspect that may be combined with any of the aspects herein,the first and second actuators are adapted to cooperatively move thefoot portion between the delivery and deployed configurations.

In another aspect that may be combined with any of the aspects herein,the device includes a first plurality of slits disposed within the footportion.

In another aspect that may be combined with any of the aspects herein,the device also includes a second plurality of slits disposed within theneedle guide portion.

The present invention may be embodied in other specific forms withoutdeparting from its spirit or essential characteristics. The describedembodiments are to be considered in all respects only as illustrativeand not restrictive. The scope of the invention is, therefore, indicatedby the appended claims rather than by the foregoing description. Allchanges which come within the meaning and range of equivalency of theclaims are to be embraced within their scope. It shall be furtherunderstood that although the present invention has been described inrelation to vessel closure, it is contemplated that the closurecomponent of the present invention may be utilized to close otheropenings in the body such as PFO openings, or openings formed in organssuch as the stomach for certain surgical procedures.

What is claimed is:
 1. A method of closing an opening in tissue, themethod comprising: positioning a member through the opening, the membercomprising a needle guide movable from an uncompressed deliveryconfiguration to a compressed deployed configuration, the needle guidecomprising a proximal portion member and a distal portion member;positioning a plurality of needles with the needle guide in thecompressed deployed configuration, each needle extending through aneedle guide aperture in the proximal portion member and a needle guideaperture in the distal portion member with an end of each needle beingdisposed distal the distal portion member; and withdrawing the pluralityof needles through tissue adjacent to the opening to withdraw a suturethrough the tissue.
 2. The method of claim 1, wherein the memberincludes the proximal portion member and the distal portion member, eachof the proximal portion member and the distal portion member including aplurality of slits.
 3. The method of claim 2, further comprisingdeploying the proximal portion member and the distal portion member fromthe delivery configuration to the deployed configuration, the pluralityof slits facilitating changing of each of the proximal portion memberand the distal portion member from the delivery configuration to thedeployed configuration.
 4. The method of claim 3, wherein the deliveryconfiguration has a smaller cross-sectional size than the deployedconfiguration.
 5. The method of claim 1, wherein positioning theplurality of needles further comprises proximally advancing each needleof the plurality of needles into a cuff.
 6. The method of claim 1,further comprising axially compressing the tissue between the needleguide and another distal portion.
 7. A method of closing an opening intissue, the method comprising: positioning a body member through theopening, the body member comprising a proximal portion that is axiallymovable toward a distal portion in a deployed configuration, theproximal portion and the distal portion radially move from a deliveryconfiguration to the deployed configuration with a living hinge betweenthe proximal portion and the distal portion, an end of the body memberdisposed distal the distal portion; positioning a plurality of needlesthrough the tissue with the proximal portion and the distal portion inthe deployed configuration, each needle extending through a needle guidein the proximal portion and a needle guide in the distal portion with anend of the needle extending distally of the distal portion; andwithdrawing the plurality of needles and a suture through the tissue. 8.The method of claim 7, wherein the proximal portion is overlapping thedistal portion along a longitudinal axis of the body member.
 9. Themethod of claim 8, wherein the proximal portion includes another needleguide.
 10. The method of claim 7, wherein the body member comprisesanother distal portion, the another distal portion including a thirdportion and a fourth portion, the third portion overlapping the fourthportion along a longitudinal axis of the body member, the tissue beingaxially compressed between the another distal portion and the distalportion in the deployed configuration.
 11. The method of claim 10,wherein each needle is supported by the distal portion when the needleis received in the distal portion.
 12. The method of claim 7, whereinwithdrawing the suture further comprises withdrawing the plurality ofneedles proximally to withdraw the suture through the tissue.
 13. Amethod of closing an opening in tissue, the method comprising:positioning a body member through the opening, the body membercomprising a proximal portion and a distal portion; radially moving theproximal portion and the distal portion from a delivery configuration toa deployed configuration, the radial movement aligning needle aperturesformed in the proximal portion and the distal portion in a longitudinaldirection; and with a needle extending through the aligned needleapertures in both the proximal portion and the distal portion, movingthe needle, with a suture connected to the needle, proximally to movethe suture radially from a relief slit in a distal member distal thedistal portion and move the needle through tissue adjacent to theopening to withdraw the suture through the tissue.
 14. The method ofclaim 13, further comprising another distal portion and moving a firstactuator operatively associated with the body member to cause theanother distal portion to change between the delivery configuration andthe deployed configuration.
 15. The method of claim 13, furthercomprising moving a second actuator operatively associated with the bodymember to cause the proximal portion and the distal portion to changebetween the delivery configuration and the deployed configuration. 16.The method of claim 13, wherein the body member is configured as alocator.
 17. The method of claim 13, wherein the suture is connected toa pair of cuffs.
 18. The method of claim 13, wherein each of theproximal portion and the distal portion comprises a plurality of legs.